MAUDE Adverse Event Report: DUO BATTERY HOLSTER - QUANTITY ONE; PFM05

Catalog Number 90621

Device Problems Overheating of Device (1437); Ambient Temperature Problem (2878)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 3 of 3 reports which are linked to mfg report numbers: 2523190-2020-00150; 2523190-2020-00151.A facility reported that while the surgeon was using the headlight during a spinal case, the lithium ion battery began to get hot on his hip.It was taken off and there was liquid coming from the battery.Additionally, the knob of the duo battery holster was also coming off and was being held on with tape.There was no patient injury and the surgeon's condition was fine.There was a delay in surgery of 1 to 3 minutes to change the batteries.

Manufacturer Narrative

Unique device identifier (udi #): (b)(4).Device history record (dhr) - dhr shows no abnormalities related to the reported issue.The returned 90621 duo battery holster was in used condition with the control knob broken off due to physical damage.The reported complaint is confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: DUO BATTERY HOLSTER - QUANTITY ONE
• Type of Device: PFM05
• MDR Report Key: 10983312
• MDR Text Key: 220714375
• Report Number: 2523190-2020-00152
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1